Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT00703092
Eligibility Criteria:
Inclusion Criteria:
* Women with PCOS between the ages of 18-45 years and with a body mass index of less than or equal to 45
* Less than or equal to 8 periods annually
* elevated serum free testosterone concentrations
* normal thyroid function tests and serum prolactin
* exclusion of late-onset adrenal hyperplasia
* acceptable health based on interview, medical history,physical examination, and lab tests
* ability to comply with the requirements of the study
* ability and willingness to provide signed, witnessed informed consent
Exclusion Criteria:
* Diabetes mellitus
* Clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease
* high blood pressure
* current or recent(within 2 months prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives,metformin,thiazolidinediones,glucocorticoids, GnRH-agonists, or anti-androgens (spironolactone,flutamide,etc)
* documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism
* ingestion of any investigational drugs within 4 weeks prior to study onset
* pregnancy or lactation(less than or equal to 6 weeks postpartum)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00703092
Study Brief:
Protocol Section:
NCT00703092